Type of study

Target number of patients

Date of activation

Date closed

Approved by

Study objectives

Evaluation of the effect of an escalated dose of Daunomycin in induction treatment Evaluation of the effect of maintenance treatment with GO (gemtuzumab ozogamicin, anti-CD33-calicheamycin) for patients in CR.

2. Patient eligibility criteria

Inclusion criteria

Age 61 years or more Subjects with a cytopathologically confirmed diagnosis of (a) AML (M0-M2 and M4-M7, FAB classification, appendix A), or (b) with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >=1.5 (appendix B) Subjects with a secondary AML progressing from antecedent myelodysplasia and biphenotypic leukemia are eligible. Antecedent MDS refers to any antecedent hematological disease of at least 4 month duration WHO performance status <= 2 (see appendix E) Written informed consent